GB2518855A

GB2518855A - Pleated ostomy bag

Info

Publication number: GB2518855A
Application number: GB1317445.3A
Authority: GB
Inventors: Kim Frampton; Tim Thorndale
Original assignee: Welland Medical Ltd
Current assignee: Welland Medical Ltd
Priority date: 2013-10-02
Filing date: 2013-10-02
Publication date: 2015-04-08
Anticipated expiration: 2033-10-02
Also published as: GB201317445D0; GB2518855B

Abstract

An ostomy bag 10 comprises an inlet 12 leading to a waste collection space 8 defined by two opposing surfaces of two walls 1, 11. The opposing surfaces 1, 11 are configured to separate on the introduction of waste through the inlet 12 and in at least one of the walls at least one pleat 5 is provided. The pleat 5 extends horizontally, relative to the longitudinal axis of the ostomy bag 10 and is in the lower portion of the bag. The pleat 5 may be single, double or box pleat. The ostomy bag 10 is expandable to provide a sufficient volume for waste. A mounting plate 13 abuts inlet 12.

Description

PLEATED OSTOMY BAG

The present invention relates to an ostomy bag for collection of waste from a human or animal body. In particular the invention provides a pleated ostomy bag. In addition, the invention provides an ostomy bag with specific design features addressing the problem of providing a discrete ostomy bag that is expandable to provide a sufficient volume.

Background of the Invention

Ostomy bags are medical devices that are worn by an individual and they can be used for the collection of waste from a surgically diverted bowel or urinary system of the individual. They are used to collect waste that is output from a stoma created in the ostomate's skin and connected to the intestine or urinary system.

Known ostomy bags comprise a collection bag and in some cases the collection bag is attached mechanically or with adhesive to a mounting plate, commonly referred to as a wafer or a baseplate. The mounting plate is fixed to the skin of an individual and the ostomy bag allows the waste to drain from a stoma into the collection bag, while protecting the surrounding skin from contamination by the waste.

Ostomy bags should be air-and water-tight and they should allow the individual to lead an active normal lifestyle that can include all forms of sports and recreation. However, there is a need to make ostomy bags discrete.

The need to provide discrete ostomy bags must be balanced with the need to provide a sufficiently large collection bag so that unexpected deposits can be accommodated by the bag. For example, if an individual suffers from an upset bowel, the bag should not overflow. Typically, ostomy bags are emptied at least once per day.

Pancaking is a term used to describe the situation where large quantities of soft waste are deposited with speed to the inlet of a clean ostomy bag, they stick to the immediately opposing inner surface of the bag, blocking the inlet and preventing use of space distanced from the outlet. As a consequence of pancaking, despite there being available capacity in the bag, the bag can overflow when subsequent deposits are attempted.

The present invention seeks to provide an ostomy bag which addresses one or more of the problems presented by prior art arrangements. In particular, the present invention seeks to provide an ostomy bag which is discrete. In addition, the present invention seeks to provide an improved ostomy bag which is discrete and is expandable to provide a sufficient volume.

Summary of the In vent/on

Remarkably, it has now been found that an ostomy bag can be provided that is expandable. This provides the advantage that an ostomy bag can be provided that has a smaller and more discrete appearance than known ostonly bags, but it is capable of containing the same volume as larger known ostomy bags.

In accordance with the present invention, there is provided an ostomy bag having an inlet leading to a waste collection space defined by two opposing surfaces of two walls, the opposing surfaces configured to separate on the introduction of waste through the inlet and including in at least one of the walls at least one pleat.

Preferably, the walls are joined, preferably by being welded together at their edges.

Preferably, a mounting plate abuts the inlet.

Preferably, the at least one pleat is provided in the wall opposing the inlet.

Preferably, the pleat is deformable under the weight of waste in the bag.

Advantageously, when the bag fills, deformation of the pleat allows the opposing surfaces of the bag to separate, thereby expanding the apparent size of the bag.

Preferably, the at least one pleat extends substantially perpendicular to the longitudinal axis of the bag and is configured to open when under a substantially orthogonal force is applied through the inlet whereby in use, when an initial deposit is made through the inlet, the pleat opens thereby separating the opposing surfaces and opening the collection space for receipt of further deposits. In use, when the bag is in position on a user, the at least one pleat extends approximately horizontally.

Preferably, the pleat is configured so that, in use, it extends substantially horizontally across the bag. Preferably, the ostomy bag comprises an upper portion and a lower portion and the pleat is located in the lower portion.

The pleat may take any convenient form, for example a single pleat, a double pleat or a box pleat. By providing an additional surface area on one of the opposing surfaces the collection space can be expanded to a larger volume than conventional bags, or alternatively, other dimensions of the bag can be reduced without impact on the collection capacity to provide a more discretely sized product.

Preferably, the pleat comprises a fold formed by doubling material back upon itself and securing it in place.

The pleat is positioned so that, in use, it is lower than the inlet. As a deposit is made the bag begins to separate and the deposit collects on the immediately facing surface in which the pleat is provided. The pleat opens expanding the surface area of the opposing surface and a small space is opened between the two opposing surfaces of the bag, providing a fully open waste collection space to receive further deposits.

The amount of material included in the pleat can be varied depending on capacity required for the bag. Conveniently the pleat provides about 30% to about 50% of the overall surface of the bag wall in which it is provided.

Preferably, the pleat is located proximal to the bottom of the bag and distal to the top of the bag. This has the effect that the opposing surfaces of the bag are capable of separating more from each other at the lower portion of the bag.

Advantageously, the bag fills from the bottom and this encourages flow of deposit into the bag and assists with reduction of pancaking.

Preferably, the bag is defined by an ellipse, having an upper focus, a lower focus, an upper vertex and a lower vertex. Preferably, the pleat is located in the major sector of the ellipse wherein the sector is approximately defined by a chord through the upper focus.

Preferably, the inlet leading to a waste collection space is approximately aligned with the upper focus.

Preferably, a plurality of pleats are provided. Preferably, about one to about ten, more preferably, about one to about seven pleats are provided. More preferably, about one to about four pleats are provided. Most preferably, one, two or three pleats are provided.

Preferably, the pleats are formed by welding pleats into the wall facing the inlet when the edges of the walls are joined.

In one embodiment the ostomy bag is produced of film having a thickness of about 50 to about 100 microns. The bag is preferably of polyethylene fabric. Woven or non-woven fabric can be used, including materials such as lycra®.

Advantageously, despite the pleats being formed, the odour barrier of the bag remains intact.

The walls of the collection bag may comprise any conventional structure known in the prior art. In one preferred option, the bag comprises a laminate which has hydrophobic exposed surfaces and degradable core and means for delaminating the bag whereby to expose the degradable core and facilitate easy flushing of the bag after use.

In an alternative option, the bag comprises a disposable or degradable liner enclosed in a hydrophobic bag and means for conveniently removing the liner for disposal.

In another option, the bag may further include in an accessible wall a closable exit aperture and means for selectively releasing accumulated gas through the aperture.

The exit aperture can conveniently be resealably opened by a closure which covers the aperture and attaches to the bag by means of a peelable adhesive. The closure may conveniently be provided in the form of a sealing flap which folds down from a seam around the edge of the bag. Alternatively, the closure may comprise a patch which can be completely detached from the bag and optionally replaced with another. Alternative resealable means to a peelable adhesive will no doubt occur to the skilled addressee and include, without limitation, a mechanical seal comprising an annular rib received in an annular groove or a suction based closure means; Velcro® or sirriilar.

In use, when ballooning occurs, the user can discreetly remove the closure, gently squeeze the bag and release gas to return the bag to a comfortable size.

In other options, a valve might be used to close the exit aperture, the valve being easily activated by the user, for example by depressing or nipping an area around the aperture.

Brief Descri/Jtion of the Drawings One embodiment of a bag in accordance with the invention is now described with reference to the accompanying figures of which; Figure 1 shows a view of an ostomy bag according to the invention. . It will be appreciated that other profile types not specifically shown also fall within the invention.

The drawing shows an ostomy bag having two pleats. It will be appreciated that other numbers of pleats fall within the scope of the invention.

Figure 2 shows a cross sectional side view of an ostomy bag according to the invention in an empty state.

Figure 3 shows a cross sectional side view of an ostomy bag according to the invention in a filled state.

Figure 4 shows the result:s of a comparison of the capacity of an ostoniy bag according to the invention with known ostomy bags.

Detailed Descr4otion of the Invention It will be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that allows the specification to be written in a clear and concise way. However, unless circumst:ances clearly dictate otherwise, aspects, embodiments and preferred features can be variously combined or separated in accordance with the invention. In a preferred embodiment, a device in accordance with the invention comprises all aspects of the invention.

Within the context of this specification, the word "about" means preferably plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2/c.

Within the context of this specification, the word "comprises" means "includes, among other things" and should not be construed to mean "consists of only".

Within the context of this specification, the word "substantially" means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99%.

Within the context of this specification, the word expandable and the word expansible are taken to mean capable of being expanded. In this regard, a pleat in the wall of an ostomy bags according to the invention is capable of being opened to enlarge or increase the apparent size of the ostomy bag.

Figure 1 shows one wall 1 of two opposing walls of an ostomy bag 10 defining internally opposing surfaces. The walls are welded together along a seam 2. Box pleats 3, 4, are provided in the wall 1 and are welded into the seam 2 between the two walls. It is arranged to provide a planar surface 3 which in use faces an opposing wall of the bag having an inlet (not shown).

A pleat 3, 4 can be formed in a wall 1 of an ostomy bag 10 by welding the pleat 3, 4 into the wall 1 when the edges of opposing walls 1, 11 are joined by welding them together. Alternatively, the walls 1, 11 can be joined with adhesive.

According to the invention, the bag 10 can be a closed bag, or a drainable bag having an opening through which the bag may be drained.

It will be appreciated that an elliptical bag 10 is specifically exemplified, but bags having alternative configurations fall within the scope of the invention. For example, in an alternative embodiment the invention provides a rectangular bag.

Figure 2 shows a cross section of an empty ostomy bag 10 of the invention. One wall 11 of the ostomy bag has an inlet 12 in the face of the wall, A mounting plate 13 abuts the inlet.

As can be seen from the cross section shown in Figure 3, wall 11 of the ostomy bag has an inlet 12 in the face of the wall. The mounting plate 13 abuts the inlet. In use, deposits into the ostomy bag enter through the mounting plate 13 and the inlet 12.

The opposing wall 1, has two pleats 3, 4 located proximal to the lower vertex 7 of the bag. It will be appreciated that two pleats are specifically exemplified, but bags having alternative numbers of pleats fall within the scope of the invention. For example, in an alternative embodiment the invention provides an ostomy bag having three or five pleats.

Figure 3 shows in side view the behaviour of an ostomy bag in accordance with one embodiment of the invention.

As shown in Figure 3, when the bag is filled, the pleats deform and the opposing surfaces of the walls separate.

The ostomy bag comprises two opposing walls 1, 11, joined by a seam 2. A front wall has an inlet 12 into which a deposit 6 is received. As shown in Figure 3, on entering the inlet 12, the deposit 6 contacts the opposing planar surface 5 of the pleat and adheres to it. The orthogonal force provided by the deposit 6 on entry causes the pleat 3, 4 to open and the surface area of the opposing wall to expand thereby separating the two walls 1, 11 and opening the collection space 8.

As shown in Figure 4, an ostomy bag 10 of the invention was compared with other ostomy bags 20, 30 and it was found that an ostomy bag 20 having a standard split back had a capacity of 300m1. In addition, an ostomy bag 30 having a vertical split back had a similar capacity of 290m1. However, remarkably, an ostomy bag 10 of the invention had a much higher capacity of 350m1.

Embodiments of the invention were tested and details of the tests are described below: In this test, the pouch capacity was tested in ostomy bags having a 013mm or 032mm starter hole.

PURPOSE CE EVALUAT]DN To carry out a comparative assessment of the capacity of the pouch after the back panel has been pleated (for expandability) against other pouches.

CONCLUSION

As shown by the results the pleated ostomy bag of the invention has an increased capacity compared to conventional ostomy bags having no pleat.

SAM PLES

The samples tested are shown in Table 1.

In the table, "Sample" corresponds to the numbering of the sample. "Appearance" corresponds to representation of the sample. "Description" corresponds to a short

description of the sample. -10-

Table 1

Sample Appearance Description

1 Pleated-013mm StarterHole nta uriei \ \ . -\a 2 Pleated -032mm Starter Hole

N A; as a :fl

Ii: fl

S

TEST METHOD AND PROGRAMME

To fill pouches up to capacity (stoma level -013mm and 032mm starter hole) with a reservoir and/or syringe (filled with water), and then pour out the contents into a measuring jug to establish volume (ml).

RESULTS

Pouch Volume Type (ml) 4ppearançJffont) 013mm 330 ____ ic!uLI L!I

I

r:::.. ...

032mm 270 ______ IWJSII!I

-

____ .. _%

4 __ __

SUMMARY! COMMENTS

The results revealed that pleated ostomy bags of the invention have an increased capacity compared to conventional ostomy bags having no pleat.

As shown in Figure 4, an ostomy bag of the invention was compared with other ostomy bags and it was found that an ostomy bag having a standard split back had a capacity of 300m1. In addition, an ostomy bag having a vertical split back had a similar capacity of in

-IL -

290m1. However, remarkably, an ostomy bag of the invention had a much higher capacity of 350m1.

The above described embodiments have been given by way of example only, and the skilled reader will naturally appreciate that many variations could be made thereto without departing from the scope of the claims.

Claims

-13 -CLAIMS1. An ostomy bag having an inlet leading to a waste collection space defined by two opposing surfaces of two walls, the opposing surfaces configured to separate on the introduction of waste through the inlet and including in at least one of the walls at least one pleat.
2. An ostomy bag according to claim 1 wherein the walls are joined, preferably by being welded together at their edges.
3. An ostomy bag according to claim 1 or 2 wherein a mounting plate abuts the inlet.
4. An ostomy bag according to any preceding claim wherein the at least one pleat is provided in the wall opposing the inlet.
5. An ostomy bag according to any preceding claim wherein the pleat is deformable under the weight of waste in the bag.
6. An ostomy bag according to any preceding claim wherein the at least one pleat extends substantially perpendicular to the longitudinal axis of the bag and is configured to open when under a substantially orthogonal force is applied through the inlet whereby in use, when an initial deposit is made through the inlet, the pleat opens thereby separating the opposing surfaces and opening the collection space for receipt of further deposits.
7. An ostomy bag according to any preceding claim wherein the ostomy bag comprises an upper portion and a lower portion and the pleat is located in the lower portion.
8. An ostomy bag according to any preceding claim wherein the pleat is a single pleat, a double pleat or a box pleat.

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9. An ostomy bag according to any preceding claim wherein the pleat comprises a fold formed by doubling material back upon itself and securing it in place.
10. An ostomy bag according to any preceding claim wherein the pleat is positioned so that, in use, it is lower than the inlet.
11. An ostomy bag according to any preceding claim wherein the pleat provides about 30% to about 50°k of the overall surface of the bag wall in which it is provided.
12. An ostomy bag according to any preceding claim wherein the pleat is located proximal to the bottom of the bag and distal to the top of the bag.
13. An ostomy bag according to any preceding claim wherein the bag is defined by an ellipse, having an upper focus, a lower focus, an upper vertex and a lower vertex and the pleat is located in the major sector of the ellipse wherein the sector is approximately defined by a chord through the upper focus.
14. An ostomy bag according to claim 13 wherein the inlet leading to a waste collection space is approximately aligned with the upper focus.
15. An ostomy bag according to any preceding claim wherein a plurality of pleats are provided.
16. An ostomy bag according to claim 15 having about one to about ten pleats.
17. An ostomy bag according to any preceding claim wherein the pleats are formed by welding pleats into the wall facing the inlet when the edges of the walls are joined.

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18. An ostomy bag according to any preceding claim manufactured of polyethylene fabric.
19. An ostomy bag substantially as described herein.